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BrainStorm Cell Therapy Rejected by Panel

[ Price : $8.95]

An FDA advisory committee votes 17 to 1 against approving a BrainStorm Cell Therapeutics BLA for NurOwn, an investigational mesenc...

FDA Approves Entyvio Subcutaneous Dosing

[ Price : $8.95]

FDA approves a subcutaneous administration for Takedas Entyvio (vedolizumab) for maintenance therapy in adults with moderately to ...

Biologic Adverse Event Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Adverse Experience Reporting For Licen...

Drug Application Info Collection Revision

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Federal Register notice: FDA seeks comments on an information collection revision entitled Applications for FDA Approval to Market...

FDA OKs Amicus Pompe Disease Combo Drugs

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FDA approves an Amicus Therapeutics NDA for Pombiliti (cipaglucosidase alfa-atga) in combination with Opfolda (miglustat) 65mg cap...

265 Suicidal Reports on GLP-1 Drugs: Reuters

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According to Reuters, FDA says it is doing a thorough review of 265 reports of suicidal thoughts or behavior that may be associate...

Physiologic Closed-Loop Control Guidance

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FDA publishes a guidance on technical considerations for medical devices that use physiologic closed-loop control technology with ...

Graft-vs-Host Product Development Guidance

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FDA publishes a draft guidance to assist sponsors in developing various types of products to prevent or treat graft-versus-host di...

FDA Approves New Depression Drug

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FDA approves a Fabre-Kramer Pharmaceuticals NDA for Exxua (gepirone hydrochloride extended-release tablets) for treating major dep...

FDA OKs Pfizers Bosulif for Pediatric CML

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FDA approves a new indication for Pfizers Bosulif to treat some pediatric patients with chronic myelogenous leukemia.